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The Ivy Biomedical RT Carbon ECG Leads are intended for use in X-ray imaging environments. They connect between ECG electrodes that are placed on the patient by a trained healthcare professional and an ECC trunk cable that connects to the ECG monitoring device. The RT Carbon ECG Leads are reusable and nonsterile. The RT Carbon ECG Leads are intended for adult, pediatric and neonatal patient populations.

The RT Carbon ECG Leads are intended to connect electrodes placed on the patient to a physiological detection module or monitor (CTM-300, CTM-400, CTM-500, 7000 Series and 3000 Series). The design includes 3 and 4 lead designs with overall lengths of 24", 30" and 36".

The provided text describes a 510(k) premarket notification for the Ivy Biomedical RT Carbon ECG Leads. This document focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than presenting novel clinical efficacy or diagnostic performance data. Therefore, many of the requested categories related to AI performance studies are not applicable.

Here's the information extracted and categorized as requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance in the format of specific thresholds and measured values for the RT Carbon ECG Leads. Instead, it states that the device was "thoroughly tested from design requirements through device verification and validation testing as required by 21 CFR 870.2900" and in accordance with EC53. The reported performance is summarized as:

"The performance data support the safety of the device and hardware verification and validation demonstrate that the RT Carbon ECG Leads should perform as intended in the specified use conditions and is substantially equivalent to the predicate."

This implies that the device met the acceptance criteria derived from the listed tests.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for individual tests conducted on the RT Carbon ECG Leads. The testing was described as "conducted at Ivy" (implying in-house lab testing) and does not involve human data, thus the provenance (country of origin, retrospective/prospective) is not applicable in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/diagnostic device that requires expert ground truth establishment for a test set. The tests are engineering and biological evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/diagnostic device that requires adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ECG lead, not an AI system or diagnostic tool for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an ECG lead, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The 'ground truth' for the performance testing is based on established engineering standards (EC53) and biocompatibility standards (ISO 10993-1). Compliance with these standards serves as the benchmark against which the device's performance is measured.

8. The sample size for the training set

Not applicable. This is a medical device (ECG lead), not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a medical device (ECG lead), not an AI model.

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The Ivy Biomedical Model 7600EP/7800EP is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization, such as nuclear medicine, computed axial (CAT), or positron emission (PET) tomography and other imaging systems requiring similar cardiac cycle specific timing. The Ivy Biomedical Model 7600EP/7800EP monitors can also be used to provide cardiac trigger pulse output used by a third-party ablation and lithotripsy systems.

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I understand you're asking for details about the acceptance criteria and study data for a medical device. However, the provided text is an FDA 510(k) clearance letter for the Ivy Biomedical Model 7600EP/7800EP Cardiac Synchronization Monitor.

This document explicitly states that the device is a "Cardiac Monitor (Including Cardiotachometer And Rate Alarm)" and is intended to "provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization."

This is not an AI/ML medical device, and the provided text does not contain any information about acceptance criteria, study data, ground truth establishment, or any of the other AI/ML-specific details you are asking for.

Therefore, I cannot extract the information requested for a study proving an AI/ML device meets acceptance criteria, as the document concerns a traditional medical device.

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The MRI PPG Patient Cable is intended to connect to a parent device and facilitate the generation of continuous noninvasive peripheral pulse cardiac gating on adult, pediatric, and neonatal patients in hospital and/or health care environments.

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The provided document is a 510(k) clearance letter for the "MRI PPG Patient Cable" and contains "Indications for Use" information. It does not include details on acceptance criteria or a study proving that the device meets such criteria.

The information provided describes the device's intended use and regulatory classification, but it does not delve into its performance metrics, how those metrics were evaluated, or any studies conducted to validate its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given text. The document focuses on regulatory clearance rather than technical performance validation.

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The MRI ECG Patient Cable is intended to connect electrodes placed on a patient to a host device. The cable is intended for use in up to 3.0T in MRI environments. It is used in a professional healthcare facility environment.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (MRI ECG Patient Cable). This letter does not contain any information about acceptance criteria, study details, performance data, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given document. The letter only states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

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The Ivy MR Wireless Gating System's intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition of gated images during MRI scanning in systems operating at 3.0 Tesla in strength.

The MR Wireless Gating System is intended for use on adult and pediatric patients.

This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring.

The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.

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I am sorry, but the provided text from the FDA 510(k) K171778 letter for the "Ivy MR Wireless Gating System, Model WGS-100" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The document is an FDA clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices. It covers:

• Device Name: MR Wireless Gating System, Model WGS-100
• Regulation Number and Name: 21 CFR 892.1000, Magnetic Resonance Diagnostic Device
• Regulatory Class: Class II
• Product Code: LNH
• Indications for Use: To acquire physiologic signals (ECG, PP, RESP) to provide reference outputs to trigger gated MRI acquisition at 3.0 Tesla, for adult and pediatric patients, in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners. It also specifies limitations (e.g., not for diagnosis, treatment, life support, one patient at a time, not for home care monitoring, not for providing diagnostic clinical information).
• General Controls: Details requirements such as registration, listing, good manufacturing practice, labeling, etc.

The document does NOT include:

1. A table of acceptance criteria or reported device performance data.
2. Information on sample sizes, data provenance, number of experts, adjudication methods for test sets.
3. Details about MRMC comparative effectiveness studies or standalone performance.
4. Type of ground truth used.
5. Sample size for training sets or how ground truth for training was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. To get this information, you would typically need to refer to the full 510(k) submission summary or associated testing reports, which are not included in this FDA clearance letter.

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The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization.

The Model 7600/7800 is intended for use in neonatal, pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals.

The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.

The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization.

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for the Ivy Biomedical Systems Cardiac Trigger Monitor, Models 7600 and 7800. It outlines the regulatory classification, indications for use, and general requirements for marketing the device.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided input.

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The Ivy Biomedical Model 7810 ("7810") is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization.

The 7810 is intended for use in pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals.

The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.

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I apologize, but the provided text from the FDA 510(k) summary for the Ivy Biomedical Systems, Inc. 7810 Cardiac and Respiratory Synchronization Monitor does not contain the specific details required to answer your full request regarding acceptance criteria and study design.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but it does not include a detailed scientific study, acceptance criteria, or performance metrics from such a study for the device itself.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not available. This type of study is typically for AI-assisted diagnostic tools, and the 7810 monitor is described as a basic cardiac monitor providing trigger pulse outputs for third-party systems.
6. If a standalone performance study was done: While the FDA clearance implies some testing was done to demonstrate substantial equivalence, the details of such a standalone performance study (including specific metrics and acceptance criteria) are not in this document.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

What the document does tell us:

• Device Name: 7810 Cardiac and Respiratory Synchronization Monitor
• Intended Use: "The Ivy Biomedical Model 7810 ("7810") is a basic cardiac monitor used to provide cardiac and respiratory trigger pulse outputs used by third-party systems that require ECG or respiratory synchronization. Cardiac and respiratory synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization."
• Patient Population: Pediatric and adult patients undergoing diagnostic imaging and related procedures. The "Patient Population" section further states it's for "adult, geriatric, pediatric and neonatal patients."
• Contraindications: Not for life support, home monitoring, or MRI environment. Also, not for performing cardiac diagnostics.

To obtain the detailed performance data, acceptance criteria, and study information you're looking for, you would typically need to consult the complete 510(k) submission, the device's user manual, or scientific publications from the manufacturer (if any R&D studies were published). The provided document is merely the FDA's clearance letter.

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The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 7600 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.

The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization.

Based on the provided text, the document is a 510(k) clearance letter for the Ivy Biomedical Model 7600 Cardiac Trigger Monitor. It confirms the device's substantial equivalence to a predicate device but does not contain information regarding detailed acceptance criteria, performance studies, or technical specifications of the device's performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document focuses on regulatory clearance, not the technical validation of the device's performance against specific metrics.

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The Model 6000 is intended to provide continuous noninvasive monitoring of SpO2 and EtCO2 indications. The parameters are derived from both the measurements of arterial oxygen hemoglobin saturation and pulse rates as well as relative expired and inspired CO2 levels. The recorded data may be displayed locally and also transmitted wirelessly to any device supporting the 802.11 communication protocol.

This device is intended for use on adult, geriatric, and neonatal patients in bedside or mobile applications within health care institutions and/or health care environments only under the direction of a physician or qualified clinician.

The device is a two parameter patient monitor. Both EtCO2 and SpO2 parameters are derived from commercially available modules that are incorporated internally. The device displays the waveforms and numerical values associated with each parameter on a color LCD display, and transmits the information to a network based computing device over the 802.11a - g IEEE wireless protocol. The device is intended for use on adult, geriatric, pediatric, and neonatal patients only under the direction of a physician or qualified clinician.

The provided text describes a 510(k) summary for the Ivy Biomedical Systems Model 6000 Two Parameter Bedside Monitor. It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, it does not include specific information about acceptance criteria for performance metrics (e.g., accuracy, precision for SpO2 or EtCO2) nor a dedicated study section with the detailed information requested in the prompt (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.).

The document states: "The device was verified and validated according to the product specifications. The test criteria consist of standardized levels and internal product requirements. Tests performed on the device include environmental and mechanical stress testing, electromagnetic immunity and emissions testing, and medical device safety testing. Software on the device was verified and validated according to the functionality of the operations of the device. The test results confirm that the device is in accordance with its specifications."

This summary indicates that performance and safety testing were conducted internally, aligning with various industrial and medical device standards (UL 60601-1, IEC 60601-1-2, etc.). However, it does not explicitly state the quantitative acceptance criteria for SpO2 and EtCO2 accuracy, nor does it present the results of such performance tests in a format that allows for the construction of the requested table or detailed study description.

Therefore, for many of the requested points, the information is not available in the provided text.

Here is a summary of what can and cannot be extracted from the provided text based on your prompt:

Acceptance Criteria and Study for Model 6000 Two Parameter Bedside Monitor

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document broadly states that "The device was verified and validated according to the product specifications. The test criteria consist of standardized levels and internal product requirements. The test results confirm that the device is in accordance with its specifications." However, it does not provide specific numerical acceptance criteria or reported performance values for parameters like SpO2 or EtCO2 accuracy which would typically be included in a detailed performance study for such a device.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document implies internal testing and compliance with various international standards (UL, IEC, ISO, CAN/CSA, CISPR), but no details on clinical data collection are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. This device is a monitor measuring physiological parameters, not an diagnostic imaging or interpretation device that would typically rely on human expert consensus for ground truth on a test set. The ground truth for such devices usually involves highly accurate reference measurement equipment. However, the document does not detail how the ground truth for its performance validation (e.g., SpO2 or EtCO2 accuracy) was established.

4. Adjudication method for the test set:

• Not applicable/Not specified. Given the nature of the device (physiological monitor), an adjudication method in the context of expert review is not typically relevant as it would be for AI-driven interpretation tasks.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Not specified. The Model 6000 is a patient monitor, not an AI-assisted diagnostic tool that interprets data for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The device is a standalone monitor. Its performance would inherently be evaluated in a standalone manner, measuring its accuracy against reference standards. However, the details of such standalone performance testing (e.g., specific accuracy metrics, methodologies) are not provided in this 510(k) summary beyond the general statement of "verification and validation."

7. The type of ground truth used:

• Not specified. For physiological monitors, ground truth typically involves highly accurate, gold-standard reference devices (e.g., a CO-oximeter for SpO2, a calibrated gas analyzer for EtCO2). The document mentions that "EtCO2 and SpO2 parameters are derived from commercially available modules that are incorporated internally," implying these modules themselves may have established accuracy, but it doesn't detail the validation of the integrated system against an independent ground truth.

8. The sample size for the training set:

• Not applicable/Not specified. This device is a physiological monitor, not a machine learning model that requires a "training set." Its functionality is based on established engineering principles and commercially available modules, rather than learned patterns from a large dataset.

9. How the ground truth for the training set was established:

• Not applicable. As there's no mention of a training set for a machine learning model, this question is not relevant to the described device.

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The Universal Physiological Measurement Module is intended for use on patients requiring Rwave synchronization and timed imaging studies. Applications include: gamma cameras, TMR/PMR, multislice CT, PET/CT, and SPECT/CT.

The UPMM is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.

Universal Physiological Measurement Module (UPMM)

This document is a 510(k) clearance letter from the FDA for a device called "Universal Physiological Measurement Module (UPMM)". It is not a study report or clinical trial documentation. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document states that the FDA reviewed a "Section 510(k) premarket notification" and determined the device is substantially equivalent to legally marketed predicate devices. This means the device met the regulatory requirements for 510(k) clearance at the time, which typically involves demonstrating that the new device is as safe and effective as an already legally marketed device. However, the clearance letter itself does not provide:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets, data provenance, number of experts, or adjudication methods for any studies.
• Information on comparative effectiveness studies (MRMC) or standalone performance studies.
• Information on ground truth establishment for test or training sets, nor the sample size of any training sets.

In summary, based on the provided text, it is not possible to answer your questions as the document is an FDA clearance letter, not a scientific study report.

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